Case study:
Humacyte Picks Access Orchestrate to Aid in Making a Game-Changing Biopharma Breakthrough
Access Orchestrate stood out as the top choice when it came to selecting cutting-edge manufacturing software for planning.
Business size
Medium
Industry
Biopharmaceuticals
Product
Access Orchestrate
Challenge
With plans to scale-up production of its innovative Human Acellular Vessel (HAV) product, Humacyte’s complex planning schedule was kept together with Excel and Outlook.
Approach
Humacyte chose Orchestrate Advanced Planning Software to tackle bringing the product out of clinical trials and towards commercial use.
Results
Humacyte now has a system ready to handle the months-long manufacturing process of a live product, with no concerns over human error leading to financial loss.
I also think the ‘What if’ analysis was honestly the icing on the cake for us. It wasn’t something we had really expected to get out of this software, but when we saw that functionality it was an extra star for us.
Humacyte’s HAV innovation saves limbs of frontline soldiers in the War on Ukraine
Based in North Carolina, Humacyte’s aim is to revolutionize medicine with its state-of-the-art Human Acellular Vessel (HAV) product.
This bioengineered human tissue, which grows in a tube shape in controlled conditions, has endless use-cases, from AV access for dialysis patients through to saving those who have experienced vascular trauma.
Resistant to infection with an 18-month shelf life, the HAV is an innovation which will transform medicine as we know it. Humacyte’s technology has only touched the surface of its potential, with research now testing its ability to help type-1 diabetes patients and even grow organs for transplant.
Watch video: Humacyte’s Director of Manufacturing, Matt Panning, spoke to Access about how Humacyte’s HAV innovation has already been used to save limbs of frontline soldiers in the War on Ukraine.
Advanced Planning Beyond Excel
Humacyte’s groundbreaking products demand a complex manufacturing process which requires precise timings and multiple planned stages. Being a pioneer in the market (Humacyte was the first product to receive the Food & Drug Administration’s Regenerative Medicine Advanced Therapy (RMAT) designation), a compliant process needed to be developed from scratch.
During its startup phase, Humacyte managed this using the Microsoft suite, including intricate Excel spreadsheets and scheduling via Outlook.
Watch video: Matt Panning elaborates on the planning process utilized by Humacyte during its initial clinical phase and discusses why the necessity for Orchestrate became evident.
Why Access Orchestrate Is Ideal for Humacyte's Expansion Plans
Manufacturing a biologic product requires an exceptionally precise planning process to ensure the regulated device is both high quality and validated. Any errors lead to the loss of a batch – in some cases leading to a six-figure loss.
Humacyte’s production process is also cross-functional – with many groups involved in different stages of production.
When scaling up, biologic products require Advanced Planning & Scheduling Software in order to retain control and visibility across a project. Access Orchestrate's advanced features aid pharmaceutical companies like Humacyte in optimizing their production process, identifying scheduling conflicts and constraints weeks in advance.
Watch video: Matt Panning explains the planning precision needed for biologics production.
The Access Group’s Customer Support & Industry Expertise
Access Orchestrate offers a wealth of features essential for biopharma companies to effectively optimize batches, including advanced 'what-if?' analysis and tracking multiple batches within a single system.
Drawing on our extensive industry experience, The Access Group was able to understand the specific needs of a groundbreaking product like Humacyte and provide the advanced solution needed.
We achieved this through on-site visits to North Carolina and support from our consultants who have a deep knowledge of the industry and its requirements.
Watch video: Matt Panning explains why The Access Group experience put us ‘head and shoulders’ above other vendors during Humacyte’s discovery process.
